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As part of its effort to address the shortage of medical equipment needed to address the COVID-19 pandemic, FDA has issued a new Enforcement Policy announcing flexibility in some of the regulatory requirements for ventilators, accessories, and other respiratory devices.
Today, Governor Larry Hogan has taken his most aggressive measure yet to protect public safety and prevent COVID-19’s spread. Effective at 8:00 p.m., today, he has ordered everyone who resides in Maryland to remain at home.
Over the past weekend, the FDA issued yet another Final Guidance to relax the rules governing medical devices.
Elliott M. Kroll, Julius A. Rousseau, III, James M. Westerlind, Eric A. Biderman, Mark S. Fragner, Richard G. Liskov
In some of our previous Legal Alerts concerning insurance coverage for coronavirus related issues, we have highlighted some of the types of coverage that could apply to a COVID-19 related loss, such as business interruption, contingent business interruption, civil authority, and event cancellation.
As the coronavirus pandemic continues to impact employers’ business operations, employers with unionized workforces are faced with making business decisions while fulfilling their obligation to bargain with their employees’ collective bargaining representatives.
Stay at home orders. Social distancing measures. We talked with Mark Bloom and Andrew Ross about the impact state and local orders are having on the construction industry. The top question on everyone’s mind: can projects move forward right now?
Department of Justice Directed to Prioritize Investigation and Prosecution of COVID-19-Related Fraud
On March 16, 2020, United States Attorney General William Barr issued a memo directing all U.S. Attorneys to prioritize the detection, investigation, and prosecution of COVID-19-related fraud, amid reports of scams, malware, and other fraudulent efforts designed to capitalize on the pandemic.
Consumers are stuck at home. How does business continue? We talked with Aaron Jacoby and Russ McRory about the impact of state and local “Stay at Home” orders in California and New York and how dealers and manufacturers can navigate the COVID-19 pandemic.
REVISED ALERT: Impact on New York Dealership Operations of Governor Cuomo’s PAUSE Executive Order – Sales Now Deemed “Essential” with Restrictions
On Friday, March 20, Governor Andrew Cuomo signed the “New York State on PAUSE” Executive Order (“PAUSE,” Executive Order No. 202.8: Continuing Temporary Suspension and Modification of Laws Relating to the Disaster Emergency).
On March 27, 2020, President Trump signed into law the Coronavirus Aid, Relief and Economic Security Act (CARES Act), a Senate bill passed just days earlier in response to the public health crisis that has emerged from the spread of COVID-19.
To address the COVID-19 national emergency, hospitals throughout the country are seeking to bolster their ranks of health care providers.
This updates our prior Alert regarding the importation and distribution of face masks and respirators to be used to meet the significant US health care challenges posed by the COVID-19 pandemic.
COVID–19 Duty Deferral Option Withdrawn by CBP Amidst Continued Requests by Congress for Such Action
After initially accepting requests from importers in light of the novel coronavirus (COVID–19) pandemic to defer payment of duties—a means of relief that the Trump Administration had reportedly been considering—US Customs and Border Protection (CBP) has issued guidance withdrawing this option.
Governor Cuomo directed the Empire State Development Corporation (ESD) on March 27, 2020 to update New York State’s Guidance for various businesses, including construction, under the Governor’s New York State on “PAUSE” Executive Orders (EO 202.6 and thereafter).
The DHS and ICE have issued Guidance Documents, Frequently Asked Questions, and a Reporting Template to guide higher education officials in staying in compliance with the applicable rules.
Arent Fox continues to monitor the FDA activities and scientific reports on COVID-19 and the novel coronavirus.
D. Jacques Smith, Randall A. Brater, Alexander S. Birkhold, Michael F. Dearington, Mohammed T. Farooqui, Rebecca W. Foreman, Nadia Patel, Melissa A. Trenk, Laura Zell
Headlines that Matter for Companies and Executives in Regulated Industries
The Department of Labor Issues New Guidance Explaining Paid Sick Leave and Expanded Family and Medical Leave Under the Families First Coronavirus Response Act
On March 24th, the Department of Labor’s Wage and Hour Division issued its first round of guidance regarding the Families First Coronavirus Response Act.
Reference Guide: Worldwide Export Controls on Face Masks and Other Medical Personal Protective Equipment
A number of governments have imposed export controls on the export of a variety of medical (and industrial) PPE. In other words, if you want to import face masks into the US from a European country, you need a license to export them from the EU first.
CMS Announces Prioritization of Survey Activities & Expected Self-Assessments for All Providers and Suppliers
The Centers for Medicare and Medicaid Services (CMS) issued a memorandum to State Survey Agency Directors that provides further guidance regarding survey priorities for health care facilities, providers, and clinical laboratories due to COVID-19 and other respiratory illnesses.
As we reported earlier this week, in an effort to increase the domestic supply of hand sanitizer, the US Food and Drug Administration (FDA) recently announced policies that temporarily relax certain requirements for the production of alcohol-based hand sanitizer.